FDA 510(k) clearances — page 264
clearances on record, most recent first.
Clearances — page 264
26,301–26,400 of 176,542- K180553 — VERIFY Spore Test Strip for S40 Sterilant
- K180572 — AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10
- K181132 — Tri-Ad 2.0 Adams Tricuspid Band
- K172147 — STAR 65
- K172242 — DripAssist Plus
- K172717 — Automatic Tissue Processing Unit
- K172889 — Infrared Thermometer
- K173005 — SURECELL Gelling Fiber Wound Dressing
- K173834 — Quantum Pump Console
- K173914 — VORTRAN Cuff Inflator (VCI)
- K180111 — ClearGuard HD Antimicrobial Barrier Cap
- K180163 — TransEnterix Senhance Surgical System
- K180356 — inui In-Home Urine Analysis Test System
- K180402 — PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
- K180711 — FUJIFILM Endoscopic CO2 Regulator GW-100
- K181082 — ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
- K181150 — ProtekDuo Mini Veno-Venous Cannula Set
- DEN180005 — OsteoDetect
- K170697 — GBR system
- K172582 — EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern
- K172665 — Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords
- K172708 — T2Bacteria Panel
- K173938 — IS-III HActive Fixture
- K180414 — EPX-4440FN Digital Video Processor with Light Source
- K180543 — GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85
- K180756 — Safety Wire Guide Introducer
- K180807 — Celling Aspiration Needle
- K180862 — Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System
- K180976 — PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels
- K181077 — ActiGraph CentrePoint Insight Watch
- K181080 — McKesson Cardiology
- K181108 — Fresenius Liberty Select Cycler
- K181136 — CS 9600
- K173722 — PATRIOT COLONIAL Spacer, SUSTAIN Spacer
- K180201 — Route 92 Medical Access System
- K180403 — ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length +1 more
- K180609 — Rodo Smilekey
- K180811 — Biograph Vision
- K181024 — DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
- K181059 — geko T-3 Neuromuscular Stimulator
- K181067 — AlignX Ankle Fusion System
- K173405 — DiLumen Endolumenal Interventional Scissors (DiLumen Is)
- K173862 — Pantheris System
- K180270 — Cellvizio 100 Series Systems with Confocal Miniprobes
- K180455 — NeuralBot
- K180662 — Arthrex FastThread Interference Screw
- K180773 — Reusable and Self-Adhesive Electrodes
- K180808 — Omni Foot Plating System
- K172729 — Polypectomy Snare
- K173395 — MECALL CLISIS SYSTEMS, Discovery RF180
- K173593 — staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch
- K173956 — Biowy PlCC Catheter
- K180197 — Erchonia FX-635
- K180220 — SAGICO OSI Spinal System by Osimplant
- K180545 — VACUETTE SAFELINK Holder with male luer lock
- K180817 — AERIAL Interspinous Fixation
- K172209 — AURA ICP MONITORING SYSTEM
- K172430 — ArgenIS Titanium Abutments
- K172813 — Esophageal Stent System
- K173108 — Smoklean
- K173110 — GRAFTSITE
- K173294 — Magnesium
- K173431 — Towako Transmyometrial Embryo Transfer Set
- K180051 — XSTAT 30, 1-Pack
- K180087 — A.M. Surgical Intramedullary Fixation Device
- K180217 — VESTEX Apparel
- K180259 — Sterile Hypodermic Needle for Single Use
- K180375 — The IQoolTM Warm System
- K180460 — Theradome LH40
- K180508 — JOULE SYSTEM
- K180524 — EEG-Now
- K180663 — LaVid FMTS DIAGNOSTIC X-RAY SYSTEM
- K180700 — KYPHON HV-R Bone Cement
- K180771 — Acro HCG Pregnancy Rapid Test
- K180876 — DTRAX Spinal System
- K180886 — Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL
- K180908 — Irrigation Tubing Bipolar Cord Set
- K181145 — Eclipse Treatment Planning System
- K181179 — BrainScope One
- DEN170086 — TrueTear Intranasal Tear Neurostimulator
- K171505 — Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
- K172480 — icotec Interbody Cage System
- K172524 — Zimmer Persona Personalized Knee System
- K172592 — CADD Yellow High Volume Administration Set with NRFit connector
- K172894 — Infrared Thermometer
- K173360 — Athena 190
- K173667 — 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes
- K173832 — InTice-C Porous Ti Cervical Interbody System
- K173931 — MindMotion(TM) GO
- K180466 — FlowTriever Retrieval/Aspiration System
- K180742 — EnsoETM
- K181023 — Mozec Rx PTCA Balloon Dilatation Catheter, Mozec NC Rx PTCA Balloon Dilatation Catheter
- K181042 — Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter
- K181111 — Navigated INFINITY Instruments
- K172675 — Varian Cervical Sleeves
- K180239 — Additive Orthopaedics Patient Specific 3D Printed Bone Segments
- K180519 — HARRIER-SA Lumbar Interbody System
- K180527 — IS3
- K180819 — One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
- K180901 — Low Dose CT Lung Cancer Screening Option
Data sourced from openFDA. This site is unofficial and independent of the FDA.